Diet Composition and Genetics: Effects on Weight, Inflammation and Biomarkers
概览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 245
- 试验地点
- 1
- 主要终点
- Weight loss
概览
简要总结
The purpose of the MENU Study is to examine whether there is a differential weight loss response to different dietary macronutrient composition (higher carbohydrate and lower fat versus lower carbohydrate and higher monounsaturated fat [MUFA] or lower carbohydrate and walnut-rich higher fat diets) in a weight loss intervention in healthy obese women, depending on insulin resistance status. Blood samples will be collected to enable analysis of potential mechanisms and differential response across subgroups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged 21 years and older
- •Have BMI \>30.0 kg/m2 and \<40 kg/m2
- •Willing and able to participate in clinic visits, group sessions, and telephone and Internet communications at specified intervals
- •Able to provide data through questionnaires and by telephone
- •Willing to maintain contact with the investigators for 12 months
- •Willing to allow blood collections
- •No known allergy to tree nuts
- •Able to be physically active
排除标准
- •Inability to be moderately physically active
- •A history or presence of a comorbid diseases for which diet modification and increased physical activity may be contraindicated
- •Currently pregnant/breastfeeding
- •Planning to become pregnant within the next year
- •Currently enrolled in a weight loss program or diet intervention study
- •Current use of weight loss medication or supplements
- •Planned surgical procedure that can impact the conduct of the study
- •Have plans to relocate from area within the next year
- •6+ months use of meds likely to cause weight gain or prevent weight loss
- •Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study
结局指标
主要结局
Weight loss
时间窗: 1 year
Weight loss response, depending on insulin status, to diets that differ in macronutrient composition: 1) higher carbohydrate and lower fat, 2) lower carbohydrate and higher monounsaturated fat \[MUFA\] or 3) lower carbohydrate and walnut-rich higher fat
次要结局
- Blood factors(1 year)
- Nutrient-gene interactions(1 year)
研究者
Cheryl Rock
Study Principal Investigator
University of California, San Diego